A document would be reconciled in the following circumstances:
- Ensure the data integrity of the printed document
- Prevent any unauthorised use of the document
- Detect any discrepancies promptly before storage
- Comply with 21 CFR Part 11, EU GMP, Annex 11, MHRA GXP Data Integrity Guidance, WHO Guidelines on Data Integrity
A document would be reconciled for the following reasons:
- All printed forms are accounted for preventing potential data breaches
- Maintain data integrity (complying with ALCOA+ principles)
- Prevent falsification
- Detect errors
- Risk Mitigation
Relevant for: Administrators / Managers / Regular Users / Read-Only Users.